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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K003313
Device Name FILAC FAS TEMP ELECTRONIC THERMOMETER
Applicant
The Kendall Company
444 Mc Donnell Blvd.
Hazlewood,  MO  63042
Applicant Contact KELLY J ROWLAND
Correspondent
The Kendall Company
444 Mc Donnell Blvd.
Hazlewood,  MO  63042
Correspondent Contact KELLY J ROWLAND
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/23/2000
Decision Date 01/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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